Cleared Traditional

MDE ESCORT 1000 & MDE ESCOR 2000 (K842716) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842716 · Medical Data Electronics · Cardiovascular device
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Feb 1985
Decision
210d
Days
Class 2
Risk

K842716 is an FDA 510(k) clearance for the MDE ESCORT 1000 & MDE ESCOR 2000. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on February 8, 1985 after a review of 210 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Data Electronics devices

Submission Details

510(k) Number K842716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1984
Decision Date February 08, 1985
Days to Decision 210 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 125d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 54
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K842716.
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